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1,628 result(s) for "Vertigo - therapy"
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Digital vertigo therapy: study protocol for a confirmatory randomized controlled trial in patients with vestibular vertigo
Background Vestibular vertigo is one of the leading causes of disability. The clinical standard of care for vestibular vertigo includes physical activity producing central vestibular compensation (CVC). Home exercises are considered an integral part of physical therapy. However, a reliable solution is still needed to support the regular and correct execution of home exercises. For this purpose, VH-90-D DiGA was developed, which is a digital therapeutic (DTx) for multimodular in-home therapeutic training. Objective The purpose of this study is to assess the clinical efficacy and safety of a vestibular health app for patients with vestibular vertigo. Methods A randomized group-controlled single-blinded clinical trial (RCT) has been designed. Patients will be randomly assigned to one of two treatment groups and the endpoints examined in a pre-determined order. The experimental group receives the DTx (around 15 min/daily for 90 days), and the control receives physiotherapy according to the German statutory health care plan (usually 6 × 20 min of live physiotherapy). The primary outcome will be vertigo intensity measured using the German version of the validated Vertigo Symptom Scale-short form VSS-sf-VER (0–32 score points). Evaluation is performed after 2, 6, and 12 weeks. Primary outcomes are determined by measuring the group differences of the VSS-sf-score point changes from baseline to week twelve. Including dropouts, the sample size has been determined to be 2 × 100. Expected results It is expected that therapy with the DTx will be statistically superior to physiotherapy in terms of effect size. Discussion This trial protocol marks a confirmatory RCT (GEVE II) to investigate the efficacy and safety of a digital vertigo treatment. The planned RCT is based on a series of primary and secondary efficacy variables. Examination of the endpoints in a pre-determined order ensures the rigor of confirmatory statistics and addresses the challenge of multiplicity. This sequential testing continues until significance is achieved. However, if a specific variable fails to reach significance, subsequent variables will be explored solely on a descriptive basis. Trial registration German National Registry of Clinical Studies (DRKS00028026), a WHO ICRTP registry. Registered on December 12, 2023.
DIZZiness treatment through implementation and clinical strategy Tactics-2 (DIZZTINCT-2) project—a clinical trial protocol
Background The evaluation and management of acute vertigo presentations is challenging for both patients and physicians. Benign paroxysmal positional vertigo (BPPV), acute unilateral vestibulopathy (e.g., vestibular neuritis), and stroke are priority diagnostic considerations in this circumstance. Existing evidence can be used to guide the diagnosis and treatment, however high value care opportunities—such as the Dix-Hallpike test (DHT), canalith repositioning maneuver (CRM), and gaze stabilization exercises (GSE)—are often underused, while neuroimaging studies are often overused. Methods This trial contains a health system focused stepped wedge intervention and an embedded individually patient randomized clinical trial. The study will start with a 6-month pre-intervention period. This will be followed by staggered intervention at the engaged EDs in 11 waves and then an approximately 6-month post-intervention period. Concurrently, patients will be recruited before and after the physician level intervention is implemented at each ED. Enrolled participants will complete baseline survey and then be randomized individually, stratified by sex, age, and medical center, to the intervention or control arm patient materials using central computerized randomization. The intervention arm will be sent intervention materials and the control arm will be sent the hospital’s standard post-discharge materials. The primary outcome of the physician-based part of the trial is use of evidence-based care practices during the index ED visit. The primary outcome of the patient focused part of the trial is the dizziness handicap index over 4 weeks. Discussion The DIZZTINCT-2 trial addresses key areas of uncertainty in how to improve the care of emergency department patients with acute vertigo. In addition, follow up data on how much and how fast patients improved was needed. DIZZTINCT-2 will address these key knowledge gaps efficiently. Trial registration Clinicaltrials.gov NCT05634902. Registered on November 2022.
Computerized clinical decision system and mobile application with expert support to optimize management of vertigo in primary care: study protocol for a pragmatic cluster-randomized controlled trial
Vertigo and dizziness are amongst the most common symptoms in medicine and often have a major impact on activities of daily life. Although many causes of vertigo and dizziness can easily be recognized, patients often receive inappropriate and ineffective treatment. The reasons for this are various. Because vertigo/dizziness is an interdisciplinary symptom and there is a lack of standardised diagnostic tools, it is easy to lose the overview of the possible differential diagnoses. There is evidence though, that the management of patients with vertigo/dizziness can be optimized using standardized care pathways with digital support. The present study (within the framework of “PoiSe—prevention, online feedback, and interdisciplinary therapy of acute vestibular syndromes by e-health”) aims to evaluate the implementation of a program with several interlocking components. The three main components are a computerized clinical decision system, a mobile application, a counselling and interdisciplinary educational program developed by the German Center for Vertigo and Balance Disorders (DSGZ). The study is a cluster-randomized controlled trial with a parallel-group design, as well as a detailed process evaluation. Clusters comprise of primary care physician practices in Bavaria, Germany. In the scope of the study the effectiveness, acceptability and efficiency of the intervention will be evaluated. It is anticipated that the intervention will improve the quality and efficiency of the management of dizzy patients. A higher diagnostic accuracy, optimized treatment, and disease progression monitoring is expected to improve patient-relevant outcomes and reduce health-care costs.
Assessment of inner ear morphology and function in response to local positive pressure for Ménière’s disease: a nonrandomized controlled trial
Ménière’s disease (MD) is an inner ear disorder in which the main pathological feature is endolymphatic hydrops (EH). Positive pressure therapy (PPT) using a portable device is now a second-line therapy for intractable MD when initial medical treatment fails. However, it remains unknown whether PPT causes the morphological and functional changes of inner ear in patients with active MD in accordance with reduction of vertigo attacks. In this nonrandomized controlled trial of 52 patients with MD, the volume of EH significantly decreased with reduction of vertigo attacks during 8 months of PPT combined with medications while the volume of that significantly increased with medications alone. There was no difference between Control group (n = 26) and PPT group (n = 26) regarding the vertigo control, however, PPT group achieved a significant functional improvement of vertical semicircular canals. The effect of volume reduction by PPT has been firstly demonstrated and the functional changes of all semicircular canals during PPT have been firstly examined. Morphological and functional changes in the inner ear by administrating local positive pressure are quite different from those caused by medications alone. Clinical trial registration : UMIN-CTR UMIN000041164 (registered on July 20, 2020).
Difference in the immediate effect on positional nystagmus for head positions with interval time during Epley maneuver: a randomized trial
Objectives The Epley maneuver (EM) shows immediate effect, wherein disappearance of positional nystagmus occurs soon after the EM. Our previous study showed that setting interval times during the EM reduced the immediate effect. The purpose of this study is to identify the head position for which interval time reduces the immediate effect. Methods Fifty-one patients with posterior canal type of benign paroxysmal positional vertigo (BPPV) were randomly assigned to the following three groups: 10 min interval time set at the first head position of the EM in group A, at the third head position in group B, and at the fourth head position in group C. The primary outcome measure (POM) was the ratio of maximum slow-phase eye velocity of positional nystagmus soon after the EM, compared with that measured before the EM. A large ratio value indicates a poor immediate effect of the EM. Results The POM in group A (0.07) was smallest (B: 0.36, C: 0.49) ( p  < 0.001). Discussion The interval times at the third and fourth head positions reduced the immediate effect of the EM. Our previous study showed that the effect of BPPV fatigue is continued by maintaining the first head position of the EM. BPPV fatigue constitutes fatigability of positional nystagmus with repeated performance of the Dix-Hallpike test. Our findings may be interpreted in accordance with the theory that the immediate effect of the EM is BPPV fatigue itself, because we observed that the effect of BPPV fatigue is strongest in group A.
Effectiveness of vestibular rehabilitation therapy and yoga in the management of chronic peripheral vertigo: A randomized controlled trial version 1; peer review: awaiting peer review
Background The purpose of the study was to compare the effectiveness of yoga as a form of Vestibular Rehabilitation (VR) to standard VR for managing patients with symptoms such as dizziness, disequilibrium and gait instability. Methods 150 participants based on 18-point difference in the DHI score were randomly assigned to group 1- Yoga, group 2- VR and group 3- control group using block randomization. The intervention was provided for 12 weeks. The participants were assessed for Dizziness Handicap Inventory (DHI) at baseline, 4 th, 8 th and 12 th week. Results The mean DHI for group 1(41.12±7.13) group 2 (42.96±10.54) group 3 (50.84±10.78), p<0.001 decreased significantly in group 1 and 2 when compared to baseline. There was no statistically significant difference in overall Dizziness Handicap Inventory (DHI) scores between the Yoga and Physiotherapy groups after one month; however, both groups resulted in a significant decrease in scores when compared to the control group. Similarly, by the end of the second and third months, there was no significant distinction between the Yoga and Physiotherapy groups, even though both had a considerable decrease in DHI scores when compared to the control group. Furthermore, an examination of the functional, emotional, and physical components of DHI demonstrated persistent trends of significant improvement in both the Yoga and Physiotherapy groups as compared to the control group over a three-month period. Conclusions In addition to VR, Yoga and medications administered concurrently can provide effective therapeutic effects. Yoga has an advantage over VR since it offers a customized cure for giddiness in addition to symptom relief. Yoga might be a great alternative to the conventional VR because along with enhancing overall body relaxation, it is affordable and is easy to learn.
Repositioning chair treatment procedure for cupulolithiasis: case report (with video)
Introduction A cupulolithiasis of the lateral semicircular canal is an accumulation of otolithic debris at the level of the cupula of the same canal. Its pathophysiology generally generates a specific clinical presentation. This situation can be very disabling for the patient and tricky to treat for the clinician. Case report The patient was a 70-year-old man with cupulolithiasis of the right lateral semicircular canal. We present here the conversion of cupulolithiasis to canalolithiasis using the Thomas Richard Vitton (TRV) repositioning chair, as well as the treatment of this canalolithiasis through a mechanical liberation maneuver. Conclusion The results of manual therapeutic maneuvers for Benign Paroxysmal Positional Vertigo (BPPV) are generally good regardless of the type of BPPV. It can sometimes be more challenging to resolve an ageotropic-type BPPV of the lateral semicircular canal and mechanically-assisted maneuvers using a repositioning chair may be required. Faced with symptom resistance despite attempts at multiple liberatory maneuvers, clinicians must be able to reconsider their initial diagnosis and investigate other potentially more serious origins of these symptoms. The TRV chair can be a treatment option in the management of cupulolithiasis, especially in cases where classic reduction maneuvers do not always yield good results.
To compare the recovery rates of modified Epley’s against Semont’s manoeuvres in patients with posterior canal benign paroxysmal positional vertigo: a randomized clinical trial
Introduction Benign paroxysmal positional vertigo (BPPV) is one of the commonest causes of peripheral vertigo. It is treated with various canalolith repositioning manoeuvres by changing the head positions to allow the otoconial debris to fall back from the affected canal back to the utricle. The present study has compared the rate of recovery of vertigo with modified Epley’s manoeuvres as compared to Semont’s manoeuvre in patients with posterior canal BPPV. Materials and methods One hundred and seventy patients diagnosed by positive Dix–Hallpike test as posterior canal BPPV were included in this clinical trial. Subjective analysis of vertigo was done using visual analogue scale. 85 patients each were recruited in two arms by simple randomization using lottery method. Modified Epley’s manoeuvre was administered to one group and Semont’s manoeuvre to the other. They were recalled after 2 weeks for clinical assessment with repeat Dix–Hallpike and VAS. Results Repeat Dix–Hallpike manoeuvres after two weeks revealed that 95.3 and 90.6% patients improved in Modified Epley’s and Semont’s group, respectively. After the second manoeuvre, the resolution rate was significantly higher in Semont’s manoeuvre 100% (8 out of 8 patients), as compared to 25% (1 out of 4 patients) in Modified Epley’s manoeuvre. Comparison of the mean values of VAS day 0 and VAS 2 weeks has been found to be statistically significant ( p value of < 0.001). Conclusion Both Epley’s and Semont’s manoeuvre are equally efficacious in treatment of BPPV. However, use of Semont’s manoeuvre required fewer repeat manoeuvres for complete resolution of symptoms in patients. The Semont’s manoeuvre is also comparatively easier to perform with less number of position changes, takes less time, and has no requirement of post-manoeuvre mobility restrictions. Hence, it is recommended that Semont’s manoeuvre can be routinely used for the management of PC BPPV especially in older population and patients with spinal problems.
Effectiveness of an evidence-based care pathway to improve mobility and participation in older patients with vertigo and balance disorders in primary care (MobilE-PHY2): study protocol for a multicentre cluster-randomised controlled trial
Background Vertigo, dizziness or balance disorders (VDB) are common leading symptoms in older people, which can have a negative impact on their mobility and participation in daily live, yet, diagnosis is challenging and specific treatment is often insufficient. An evidence-based, multidisciplinary care pathway (CPW) in primary care was developed and pilot tested in a previous study. The aim of the present study is to evaluate the effectiveness and safety of the CPW in terms of improving mobility and participation in community-dwelling older people with VDB in primary care. Methods For this multicentre cluster randomised controlled clinic trial, general practitioners (GP) will be recruited in two regions of Germany. A total of 120 patients over 60 years old with VDB will be included. The intervention is an algorithmized CPW. GPs receive a checklist for standardise clinical decision making regarding diagnostic screening and treatment of VDB. Physiotherapists (PT) receive a decision tree for evidence-based physiotherapeutic clinical reasoning and treatment of VDB. Implementation strategies comprises educational trainings as well as a workshop to give a platform for exchange for the GPs and PTs, an information meeting and a pocket card for home care nurses and informal caregivers and telephone peer counselling to give all participants the capability, opportunity and the motivation to apply the intervention. In order to ensure an optimised usual care in the control group, GPs get an information meeting addressing the national guideline. The primary outcome is the impact of VDB on participation and mobility of patients after 6 month follow-up, assessed using the Dizziness Handicap Inventory (DHI) questionnaire. Secondary outcomes are physical activity, static and dynamic balance, falls and fear of falling as well as quality of life. We will also evaluate safety and health economic aspects of the intervention. Behavioural changes of the participants as well as barriers, facilitating factors and mechanisms of impact of the implementation will be investigated with a comprehensive process evaluation in a mixed-methods design. Discussion With our results, we aim to improve evidence-based health care of community-dwelling older people with VDB in primary care. Trial registration DRKS, DRKS00028524 retrospectively registered on March 24, 2022.
Efficacy of Epley Maneuver on Quality of Life of Elderly Patients with Subjective BPPV
OBJECTIVES: This study aimed to evaluate the efficacy of the repositioning maneuver on quality of life in elderly patients with dizziness and/or vertigo. MATERIALS and METHODS: This controlled, prospective randomized clinical trial was conducted in elderly patients aged 65 years and above with a positive history of benign paroxysmal positional vertigo (BPPV), presence of vertigo, and no observable nystagmus during the Dix-Hallpike test, so-called Subjective BPPV (S-BPPV). Individuals were evaluated by visual analog scale (VAS) and dizziness handicap inventory (DHI). Groups were defined as treatment (treated with Epley maneuver bilaterally) or no treatment control (no treatment modality or canalith repositioning maneuver). Ten days after the first assessment, all patients were reassessed using VAS and DHI. RESULTS: A total of 50 patients were randomized into two groups: 25 to the treatment group, and 25 to the control group. No significant differences were observed for baseline VAS and total DHI scores between the groups (p=0.636, p=0.846, respectively). On the other hand, after the reassessment, VAS and total DHI scores were both significantly reduced in the treatment group (p<0.001, p<0.001, respectively), but no reduction in either score was found in the control group (p=0.216, p=0.731, respectively). CONCLUSION: This study showed that elderly patients with S-BPPV benefit from the Epley maneuver, in particular global and disease-specific quality of life. KEYWORDS: Benign paroxysmal positional vertigo, quality of life, epley maneuver, dizziness handicap inventory, visual analog scale, elderly